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Example of DTBE Program Evaluation Plan & Annual Report							Updated December 11, 2020
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PDF Versionpdf icon***Disclaimer:**The activities in this document are intended for example purposes only. The actual activities implemented as part of TB program evaluation should be identified by state or local TB program officials in collaboration with other stakeholders. The example provided here is not intended to be applied directly to any specific TB program.***Increase Use of Nucleic Acid Amplification Tests (NAAT) at Local Health Jurisdictions to Improve Treatment Initiation Performance**
**Planned Start Date: October 1, 2020 – Planned Completion Date: August 1, 2021**Background, Rationale, & Expected OutcomeIn August 2020, our state TB program completed an evaluation that identified challenges to meeting national performance targets for TB case management activities. The program evaluator led a discussion about the evaluation findings between state TB program staff and collaborating state and local partners. A main concern by partners for not meeting the national TB program objective for treatment initiation performance (initiate treatment within 7 days of specimen collection) was that local health jurisdictions (LHJs) were not utilizing nucleic acid amplification tests (NAAT). NAAT can be a rapid and efficient option to guide clinicians’ decisions to initiate patient therapy and is recommended in the guidelines for diagnosing TB in adults and children.[1] Thus, TB program staff and state and local partners collaborated to develop a strategic plan to increase the use of NAAT by LHJs, with a long-term goal of improving treatment initiation performance. This long-term goal is aligned with the 2025 national TB program objective and performance target for treatment initiation.
**Current Goal:**To increase the use of NAAT results within local health jurisdictions (LHJ).On This Page
			Evaluation Plan DetailsEvaluation QuestionsProgram FacilitatorsProgram ChallengesUse of FindingsDeliverablesObjectivesBy August 01, 2021 (Time bound), increase the use of NAAT by LHJs for three TB case groups:
Increase the proportion of sputum smear-positive TB patients with a NAAT result reported prior to a culture result from 52% to 60% (Specific, Measurable, Achievable, and Relevant)
Increase the proportion of sputum smear-negative TB patients with a NAAT result reported prior to a culture result from 47% to 55% (Specific, Measurable, Achievable, and Relevant
Increase the proportion of HIV-positive TB patients with a NAAT result reported prior to a culture result from 68% to 75% (Specific, Measurable, Achievable, and Relevant)State TB Program Objective and Performance Target for 2025: For TB patients with positive acid-fast bacillus (AFB) sputum-smear results (Specific and Relevant), increase the proportion who initiated treatment within 7 days of specimen collection from 68% to 80% (Measurable and Achievable) by August 1, 2021 (Time-bound).
Relevant National TB Program Objective and Performance Target for 2025: For TB patients with positive acid-fast bacillus (AFB) sputum-smear results, increase the proportion who initiated treatment within 7 days of specimen collection to 96% by 2025.Corresponding National TB Indicators Project Indicator*Program evaluation efforts should reflect upon the national indicators. Please indicate the core NTIP indicator(s) addressed by this evaluation. If the evaluation is not linked to an NTIP indicator, please provide an explanation of how the evaluation relates to your scope of work in the CDC Cooperative Agreement.*
**Relevant National TB Program Indicator and Performance Target for Case Management and Treatment**
**Indicator: TB Disease Treatment Initiation**
For TB patients with positive acid-fast bacillus (AFB) sputum-smear results, increase the proportion who initiated treatment within 7 days of specimen collection.
2025 National Performance Target: 96%Evaluation Plan Questions, Indicators, Analysis & Timeline**Evaluation Question**
**Indicator/****Deliverable**
**Data Source**
**Data Calculation/ Method**
**Benchmark/Target**
**Timeline**To what extent do program activities in the strategic plan with LHJs increase their use of NAAT results?
Increase proportion of pulmonary TB patients with NAAT result reported prior to a culture result for smear-positive, smear-negative and HIV-positive patients
Report of Verified Case of Tuberculosis (RVCT)
For each case group: Number of patients with a NAAT result reported prior to a culture result / Number of pulmonary TB patients X 100
Target for sputum smear-positive:
60% by 08/2021
Target for sputum smear-negative:
55% by 08/2021
HIV-positive:75% by 08/2021
Work with LHJs to begin collecting data starting in October 2020 and ending in July 2021
Analyze and report findings by August 2021Did increased NAAT use by LHJs contribute to improved treatment initiation performance?
NTIP Treatment Initiation
Number of days between specimen collection and treatment initiation by LHJs
NTIP
NTIP Treatment Initiation
Compare the median number of days from specimen collection to treatment initiation for TB patients with and without NAAT result
Target Treatment Initiation:80% by 08/2021
Fewer median days to treatment initiation for TB patients with NAAT result
Work with LHJs to begin collecting data starting in October 2020 and ending in July 2021
Analyze and report findings by August 2021**Part B: Evaluation Findings and Conclusions***(This section should be updated with submission of the annual report, if new findings are available, when the evaluation is complete.)*Is this a final report of a completed evaluation or an interim report of an ongoing evaluation? Final

Open All Close All
Evaluation Questions & Related FindingsEvaluation Question or Indicator Outcomes
**Evaluation Question or Indicator Outcomes***(Listed results are by evaluation question and per NTIP indicator, if appropriate.)*
**Benchmark****Met or Not Met**To what extent does the implemented program activities in the strategic plan with LHJs increase their use of NAAT results?
The state TB program education and training team identified 15 LHJs to implement targeted outreach activities; 13 LHJs agreed to participate in the study and integrate greater use of NAAT as a diagnostic tool for TB
Across all participating LHJs, the proportion of pulmonary TB patients with NAAT results reported prior to a culture result increased:
from a baseline of 52% to 60% at follow-up for sputum smear-positive
from a baseline of 47% to 57% at follow-up for sputum smear-negative
from a baseline of 68% to 76% for HIV-positive patients
**Met**the 60% target for sputum smear-positive
**Met**the 55% for sputum smear-negative
**Met**the 75% for sputum HIV-positiveDid increased NAAT use by LHJs contribute to improved treatment initiation performance?
The state performance on TB Treatment Initiation did not reach the target of 80% by August 01, 2021. The current state performance for TB Treatment Initiation is 71.5%. However, this is an improvement from 2020 when the performance was 68%.
Overall, TB patients with a NAAT result initiated treatment in a shorter median amount of time than those without a NAAT result.
Sputum smear-positive TB patients who had a NAAT result were more likely to start treatment in a shorter amount of time (median of 5 days) compared to sputum smear-positive patients without a NAAT result (median of 16 days).
Sputum smear-negative TB patients who had a NAAT results were more likely to start treatment in a shorter amount of time (median of 7 days) compared to sputum smear-negative patients without a NAAT result (median of 24 days).
TB patients who are HIV-positive with a NAAT results were more likely to start treatment in a shorter amount of time (median of 11 days) compared to TB patients who are HIV-positive without a NAAT result (median of 18 days).
**Not Met**with 71.5% of treatment initiation
**Met**with a lower median number of days from specimen collection to treatment initiation for TB patients with a NAAT result compared to those without a NAAT resultProgram FacilitatorsHaving a timeline and stakeholders involved in the process of developing strategies, prioritizing objectives, and establishing deadlines and activities were helpful in creating a feasible strategy and gaining buy-in from LHJs.
Using existing data and protocols already in place for data reporting to CDC was beneficial in developing a manageable timeline to complete evaluation activities and in obtaining useful findings that are relevant to national TB program objectives.Program Challenges**Major Challenges in the Evaluation for Not Reaching Targets**
While targeted LHJs increased their use of NAAT and improved their performance of TB treatment initiation, this contribution was not enough for the state to reach the national performance target. A challenge identified during the outreach process were reports by many LHJs that their NAAT ordering protocols varied compared to their partnering laboratory’s protocols, potentially causing delays. For example, there were several discrepancies in their testing and reporting schedules for when to offer a test and conduct the test, when to send the test to the lab, and when to report results back to LHJs to inform provision of treatment.Use of FindingsHow findings were used: We held a meeting with TB program staff and partnering stakeholders in August 2021 to discuss new evaluation findings and challenges. The group has developed a new strategy to facilitate working partnerships between LHJs and laboratories to improve TB testing procedures for the long-term goal of further contribution to improved program treatment initiation performance.
Gather more information on current TB diagnostic protocols from LHJs.
Gather more information on current TB testing protocols from laboratories.
Finalize a strategy and begin promoting the strategy to improve TB program treatment initiation performance.
Identify solutions to improve the data quality, completeness, and timeliness of NAAT result reporting to local health jurisdictions.
Evaluate collaboration efforts and effectiveness of targeted strategies to achieve long-term goals to achieve national TB Program objectives for laboratory reporting and case management and treatment.List of Deliverables & Dissemination PlanBrief report to share strategies and findings with LHJs, laboratories and other partners.
Comprehensive report to share with state partners, CDC colleagues and other TB programs who wish to adopt the same study or strategies.
Revised outreach materials to share with LHJs.
New plan to promote partnerships between LHJs and laboratories for the next targeted evaluation.
Success story to share with state partners, CDC colleagues and LHJs to promote use of NAAT for earlier TB diagnosis.References[1] Lewinsohn DM, Leonard MK, LoBue PA, et al. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. *Clin Infect Dis*. 2017;64(2):111-115. doi:10.1093/cid/ciw778
							
					
						Page last reviewed:  September 16, 2020					Content source: 	Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention homeTuberculosisBasic TB Factsplus iconHow TB SpreadsLatent TB Infection and TB DiseaseSigns & SymptomsTB Risk FactorsExposure to TBTB PreventionVaccinesTB & HIV CoinfectionTB and DiabetesTB TermsPersonal StoriesTesting & Diagnosisplus iconWho Should be TestedTesting for TB InfectionTesting in BCG-Vaccinated PersonsTB Screening and Testing of Health Care PersonnelTesting During PregnancyDiagnosing latent TB infection and TB diseaseTreatmentplus iconDeciding When to Treat Latent TB InfectionTreatment Regimens for Latent TB Infection (LTBI)Treatment for TB DiseaseAdverse EventsTB Treatment of Persons Living with HIVTB Treatment and PregnancyTB Treatment for ChildrenFrequently Asked QuestionsDrug-Resistant TBResearchplus iconTB Epidemiologic Studies Consortiumplus iconResearch ProjectsPublicationsTB Trials Consortiumplus iconStudy DescriptionsBackgroundBehavioral & Social Science ResearchHealth Care Settingsplus iconTB Infection Control in Health Care SettingsResources for TB Screening and Testing of Health Care Personnelplus iconFrequently Asked QuestionsTB in Specific Populationsplus iconHealth DisparitiesAsian PersonsBlack or African American PersonsHispanic or Latino PersonsChildrenPregnancyCorrectional FacilitiesPeople Experiencing HomelessnessInternational TravelersLaboratory Informationplus iconDrug Susceptibility TestingFalse-Positive Investigation ToolkitInterim Laboratory Biosafety Guidance for XDR  tuberculosis strainsModel Performance Evaluation Program (MPEP)Rapid Molecular Testing to Detect Drug-Resistant TB in the USplus iconExecutive SummaryIntroductionBackground on Tests for Molecular Detection of DRGeneral Considerations and Principles for a Molecular DR Testing ServicePossible Scenarios and Scope of Testing for a Molecular DR Testing ServiceResearch NeedsGeneral Recommendations of the Expert PanelCommunication Plan for the ReportRecommendationsReferencesPanel Members and CDC ParticipantsAppendix 1Appendix 2Appendix 3The Uses of Nucleic Acid Amplification Tests for the Diagnosis of TBplus iconGeneral ConsiderationsGeneral Recommendations of the Expert PanelRecommendations to ACET, CDC, DTBEData & Statisticsplus iconTB Incidence in the United StatesReported TB in the US, 2022 Surveillance Reportplus iconNational DataReporting Area DataRisk FactorsDemographicsTB Treatment and Case OutcomesDrug-Resistant TBMolecular SurveillanceTuberculosis in the United States, 2022 (Slide Set)Archived Surveillance Reports and Slide Sets2021 State and City ReportArchived State and City ReportsProfessional Resources & Toolsplus iconTools for Healthcare ProvidersResources for TB Programsplus iconStrengthening Civil Surgeons’ Capacity to Improve LTBI Surveillance and Outcomes Among Status AdjustersNotice of Funding Opportunity (NOFO)Program EvaluationTB Centers of ExcellenceTB Elimination AllianceTB Genotypingplus iconConventional TB GenotypingWhole Genome SequencingTB GIMSAnalytic ToolsLatent Tuberculosis Infection ResourcesPublications & Productsplus iconPatient and Public MaterialsFact SheetsGuidelinesplus iconControl & EliminationDrug-Resistant TBInfection Control & PreventionLaboratory & GenotypingTB & HIVTB in Specific PopulationsTesting & DiagnosisTreatmentVaccines & ImmunizationsArchived TB GuidelinesGuides & Toolkitsplus iconAggregate ReportsCDC TB Surveillance TrainingCore CurriculumEffective TB Interviewing for Contact InvestigationEthnographic GuidesFalse-Positive Investigation ToolkitForging Partnerships to Eliminate TuberculosisGuide to Application of GenotypingLTBI: A Guide for Primary Health Care ProvidersMantoux Tuberculin Skin Testing ProductsReport of Verified Case of Tuberculosis (RVCT)Self-Study ModulesTB Contact Investigation Interviewing Skills CourseTB eDOT ToolkitUnderstanding the TB Cohort Review ProcessNewslettersplus iconTB Notes, No. 4, 2023TB Notes, No. 3, 2023TB Notes. No. 2, 2023TB Notes. No. 1, 2023TB Notes, No. 4, 2022TB Notes, No. 3, 2022TB Notes, No. 2, 2022TB Notes, No. 1, 2022TB Notes, No. 4, 2021TB Notes, No. 3, 2021TB Notes, No. 2, 2021TB Notes, No. 1, 2021Pamphlets, Brochures, Bookletsplus iconQuestions and AnswersPatient Education SeriesTuberculosis - Get the FactsTuberculosis - The Connection between TB and HIV12-Dose Regimen for Latent TB Infection-Patient Education BrochurePostersplus iconMantoux Tuberculin Skin Test Wall ChartWorld TB DayThink TBStop TBTake on TBReports & Articlesplus iconDTBE Authored Journal ArticlesTuberculosis Laboratory Aggregate ReportsSlide Setsplus iconIntroduction to TuberculosisEpidemiology of Tuberculosis Among Non-U.S.​–Born Persons in the United States, 1993–2016Self-Study Modules on Tuberculosis, 1-5 Slide SetsThe Tuberculosis (TB) in Correctional Settingsplus iconFacilitator GuideIntroduction to TB GenotypingEpidemiology of Tuberculosis in Correctional Facilities, United States, 1993-2017Prevention and Control of Tuberculosis in Correctional and Detention FacilitiesGuidelines for Preventing the Transmission of M. TB in Health care SettingsInvestigation of Contacts of Persons with Infectious TBEpidemiology of Pediatric Tuberculosis in the United StatesTargeted Tuberculosis Testing and Treatment of Latent Tuberculosis InfectionElectronic Tools & ResourcesWeb-Based Courses & Webinarsplus iconTB 101 for Health Care WorkersContent SyndicationInfographicsplus iconSocial Media GraphicsCustomizable Take on TB Infographic with InstructionsEventsWorld TB Dayplus iconU.S. TB ChampionsHistoryFeaturesplus iconTB Risk FactorsTreating Latent TB Infection with Short-Course RegimensWorld Tuberculosis (TB) Day 2021World Tuberculosis (TB) Day 2020Linksplus iconState TB Control OfficesAbout Usplus iconMission Statement and Activitiesplus iconDTBE Strategic PlanNational TB Program ObjectivesOrganization ChartAdvisory Groupsplus iconFederal TB Task Force


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